Apr 27th, 2021
Melbourne, Australia; 27 April 2021: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2021.
Starpharma’s cash balance as at 31 March 2021 was $64.3 million.
Net operating cash outflows for the quarter were $5.8 million, including significant investment in DEP®/VIRALEZE™ clinical trials and product manufacture of VIRALEZE™, and launch-related items, e.g., EU taxation costs (expected to be refundable). Expenditure during the quarter also includes costs associated with VIRALEZE™ registration, further antiviral testing and the small safety study undertaken to support commercialisation activities, as well as expenditure on Starpharma’s three phase 2 clinical programs – for DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan.
Key recent activities and events:
- Starpharma announced a new Research Agreement with leading global pharma company Merck utilising Starpharma’s proprietary DEP® technology for dendrimer-based ADCs. Starpharma’s DEP® partner, Merck, is ranked 4th globally by total sales revenue and is a recognised leader in oncology.
- AstraZeneca advised a significant expansion of its clinical program for DEP® AZD0466, to include a multi-centre global phase 1 study with a focus on haematological tumours. The clinical expansion facilitates patient recruitment and is aimed at rapid development and approval of AZD0466.
- On 25 March Starpharma signed an exclusive commercial arrangement for VIRALEZE™ with LloydsPharmacy/McKesson UK, one of the largest pharmacy groups in the UK with around 1,400 LloydsPharmacy stores across the UK and servicing a further 14,000 independent UK pharmacies.
- On 29 March, VIRALEZE™ was launched in the UK by LloydsPharmacy, initially online and in its first week was the fastest selling product on record on LloydsPharmacy.com. Whilst it is not expected that this rate of sales will necessarily be maintained, both Starpharma and LloydsPharmacy have been very pleased with the launch of the product. VIRALEZE™ has been well received by UK consumers, and the product is now also available at LloydsPharmacy outlets in-store.
- To date, Starpharma has invoiced LloydsPharmacy $1.2 million, for the launch supply of VIRALEZE™ in the UK, with further orders to be filled between now and the end of FY21.
- Starpharma has been progressing arrangements to facilitate the launch of VIRALEZE™ in other parts of Europe in the coming weeks via viraleze.co, as well as commercial discussions with pharmacy groups.
- As outbreaks of COVID-19 continue around the world, commercial interest in VIRALEZE™ remains strong and discussions for distribution of the product in a number of markets actively continue in parallel. Starpharma is also engaged in discussions with organisations, including various sporting teams which have expressed interest in the product.
- Starpharma is leveraging the European registration of VIRALEZE™ to expedite further marketing approvals for the product as soon as practicable in other countries, including Australia.
- Dosing was completed in the VIRALEZE™ double-blinded, placebo-controlled safety study, which was undertaken to support commercialisation activities. The study involved 40 healthy volunteers, using VIRALEZE™ or placebo 4 times a day for 14 consecutive days. All participants have now completed the study. Whilst the data is not yet unblinded, both VIRALEZE™ and the placebo nasal spray were extremely well tolerated by all participants.
- Further antiviral testing of SPL7013 (VIRALEZE™ active) at the Scripps Research Institute has confirmed it is active in two additional pandemic coronaviruses - severe acute respiratory syndrome coronavirus (SARS-CoV) or “SARS” and Middle East respiratory syndrome coronavirus (MERS‑CoV) or “MERS”. SPL7013’s broad-spectrum antiviral activity is a compelling feature for the role of VIRALEZE™ today and further testing is underway in multiple COVID strains.
- DEP® irinotecan phase 2 trial continues to progress well, with more than 40 patients now recruited. Encouraging efficacy signals observed include prolonged stable disease, impressive tumour shrinkage and reductions in tumour marker levels for a number of tumour types, including breast, colorectal, ovarian, pancreatic, lung and oesophageal cancer. A patient with heavily pre-treated metastatic ovarian cancer experienced a 98% reduction of tumour marker (CA-125) following 7 cycles of DEP® irinotecan, and follow up scans showed a complete disappearance of her ovarian target tumour.
- DEP® docetaxel clinical trials continue to progress well, with more than 40 patients now recruited and encouraging efficacy signals observed, including prolonged stable disease and tumour shrinkage in patients with pancreatic, oesophageal, and gastric cancer. These impressive tumour responses include stable disease for up to 40 weeks and significant tumour shrinkage in a heavily pre-treated oesophageal cancer patient, maintained for more than 28 weeks. In addition to the monotherapy of DEP® docetaxel, Starpharma is also recruiting into a study combining DEP® docetaxel with gemcitabine. This study follows compelling data for this combination in pre-clinical human pancreatic cancer models.
- DEP® cabazitaxel phase 2 trial continues to progress well, with more than 35 patients now recruited. Encouraging efficacy signals have been observed, including stable disease, significant target tumour shrinkage and substantial tumour marker reductions (e.g., PSA), in cancers including prostate, ovarian, lung, gastro-oesophageal, head and neck and other cancers. These impressive tumour responses include significant tumour shrinkage including in prostate and ovarian cancer, in patients who have failed multiple other lines of cancer treatment.
- Starpharma’s second radiopharmaceutical candidate, DEP® HER2-lutetium outperformed in human breast cancer model - achieving complete tumour regression, outperforming Herceptin® (trastuzumab) labelled with lutetium, in a human breast cancer model (BT474).
- Further DEP® candidates are being progressed toward the clinic, including DEP®
- Starpharma is engaged in active discussions with further partners in relation to DEP® The Company’s disclosed/undisclosed partnered programs continued to progress, including with AstraZeneca, Merck and Chase Sun. Following the Merck ADC partnership, Starpharma has also initiated a number of new ADC discussions.
- Mundipharma has continued its rollout of VivaGel® BV with the launch of Betadine™ BV Gel in South Africa in March 2021. The Starpharma and Mundipharma teams continue to work together on expanding the breadth of regulatory submissions for VivaGel® BV, which has now been approved in more than 45 countries. Further regulatory submissions are underway to support additional launches of VivaGel® BV in Mundipharma’s territories.
Dr Jackie Fairley, Starpharma CEO, commented: “It has been an important quarter for Starpharma, with multiple value-adding milestones achieved in the DEP® portfolio, in addition to the commercialisation and launch of VIRALEZE™. Starpharma signed with leading global pharma company Merck, in the cutting-edge area of ADCs. We were also delighted that AstraZeneca is significantly expanding its clinical program for AZD0466 globally to support rapid development and approval of this product”.
Dr Fairley added, “Alongside these partnered DEP® programs, we also progressed our internal DEP® assets, including our three clinical stage assets which continued to recruit further patients and report impressive tumour responses, in heavily pre-treated patients who have limited options”.
“Starpharma was excited to launch VIRALEZE™ in the UK in March, ahead of our original schedule. We were pleased to partner with Lloyds/McKesson to bring this important product to consumers in the UK. We are rapidly advancing the launch of VIRALEZE™ in other parts of Europe and look forward to pursuing registrations in further countries and regions”.
The closing cash balance as at 31 March 2021 was $64.3 million. Net operating cash outflows of $5.8 million for the quarter includes significant investment in R&D ($4.3 million) and product manufacturing and operating expenses, this reflects investment in multiple phase 2 DEP® clinical programs and manufacture of VIRALEZE™. Receipts from customers and grants in the quarter totalled $0.6 million. Staffing levels remained stable with quarterly staff costs of $1.6 million, including non-executive and executive directors’ fees of $233,000.
Download ASX Announcement: Quarterly Cashflow and Activity Report (pdf, 428kb)
Mar 30th, 2021
Starpharma today confirms that Starpharma’s VIRALEZE™ antiviral nasal spray has launched in the UK by LloydsPharmacy, as announced on 25 March 2021.Read More
Mar 25th, 2021
Starpharma today announced it has signed a sales and distribution agreement for VIRALEZE™ antiviral nasal spray with LloydsPharmacy and the McKesson group in the UK. LloydsPharmacy/McKesson is one of the largest pharmacy groups in the UK and is also a major wholesaler in the UK.Read More
Mar 16th, 2021
Starpharma today announced that its second radiopharmaceutical candidate, DEP® HER2-lutetium, achieved potent and durable anticancer activity, with complete tumour regression, outperforming Herceptin® (trastuzumab) labelled with lutetium, in a human breast cancer model (BT474).Read More
Mar 3rd, 2021
Starpharma today announces new data from The Scripps Research Institute in the US and other specialist laboratories on the activity of SPL7013 against important respiratory viruses, including those responsible for past pandemics. This new data further confirms the broad spectrum antiviral properties of SPL7013 (VIRALEZE™ active), with SPL7013 blocking the spike protein of two additional important pandemic causing coronaviruses, SARS-CoV and MERS‑CoV.Read More
Feb 23rd, 2021
Starpharma announced today it had received confirmation that the VIRALEZE™ antiviral nasal spray has been successfully registered for sale in Europe, including in the UK.Read More
Feb 12th, 2021
Starpharma today announced that is has signed a Research Agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth NJ USA. Under the agreement, MSD will conduct a preclinical research evaluation of dendrimer based Antibody Drug Conjugates (ADCs) utilising Starpharma’s proprietary DEP® technology.
Feb 9th, 2021
Starpharma today announced that it had been advised by AstraZeneca of its intention to expand the clinical program for AZD0466 to include a multi-centre global Phase 1 study. The study will recruit patients with acute leukaemias.Read More
Dec 22nd, 2020
Starpharma today announced that it has received all necessary approvals to commence its clinical study for VIRALEZE™. The study will commence enrolment of healthy volunteers in Perth in early January 2021 and is expected to be completed in Q1 2021. This study is being undertaken to support commercialisation activities for VIRALEZE™, and is not a requirement to achieve EU product registration.Read More
Dec 10th, 2020
Starpharma today announced significant commercial and regulatory progress has been made for VIRALEZE™ nasal spray with the EU regulatory dossier more than 90% complete and VIRALEZE™ now on track to be registered, and ready for market in Q1 CY2021. This timing is earlier than previously announced.Read More
Nov 19th, 2020
Starpharma today announced it has completed additional testing showing potent antiviral activity of SPL7013 against human respiratory syncytial virus (RSV). RSV is a common and very contagious virus that affects the lungs and airways. RSV is most problematic in the young and the elderly and those with weakened immune systems, or chronic heart and lung disease, including asthma. More than 177,000 adults are hospitalized and 14,000 of them die due to RSV infection in the US annually. RSV is also one of the viruses responsible for the common cold.
Oct 29th, 2020
Starpharma today announced that it has completed its Share Purchase Plan (SPP), raising $3.9 million. The SPP was conducted in conjunction with Starpharma’s recent institutional placement (Placement), which together have raised a total of $48.9 million. The issue of 2.6 million new shares under the SPP will be at $1.50 per share, being equivalent to the Placement share price.
Oct 21st, 2020
Starpharma today announced that it has received a $5.7M R&D tax incentive refund which relates to the costs of research and development during the 2020 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including for COVID-19, DEP® and VivaGel® programs.Read More
Oct 20th, 2020
In this issue:
>> Starpharma is expediting the development of the SPL7013 COVID‑19 nasal spray
>> Rapid progress in the DEP® irinotecan phase 2 & preparations underway for clinical combinations
>> DEP® irinotecan in combination with immuno-oncology showed superior performance in colon cancer models
>> VivaGel® BV launched in Central & Eastern Europe and Nordic region
>> Fleurstat BVgel gains expanded TGA approval to include prevention of recurrent Bacterial Vaginosis (BV) indication
>> VivaGel® BV has now been approved in 40 countries with further submissions underway
>> Starpharma awarded $1 million MRFF funding for COVID-19 nasal spray
>> DEP® docetaxel update & patient case study
>> DEP® cabazitaxel update & patient case study
>> Multiple DEP® products showcased at AACR 2020 Annual Meeting
>> New DEP® partnership signed with Chase Sun for anti-infective program
>> AstraZeneca’s AZD0466 trial opens at MD Anderson Cancer Center
>> Starpharma creates slow release soluble DEP® remdesivir
>> DEP® partnering, including Antibody Drug Conjugates
>> DEP® lutetium; impressive efficacy in human prostate cancer model
>> Outlook, Annual Report & ESG Report & recent newsRead More
Sep 30th, 2020
Starpharma today announced that it has raised A$45 million via a placement to domestic and international institutional, sophisticated and professional investors (“Placement”). Eligible shareholders will also have the opportunity to participate, at the same price, through a Share Purchase Plan (SPP) which is expected to raise approximately A$5 million.Read More
Sep 25th, 2020
Starpharma today announced that the Australia Therapeutic Goods Administration (TGA) has approved an expansion of the marketing authorisation for VivaGel® BV (Fleurstat BVgel) to now include the indication of prevention of recurrent bacterial vaginosis. These expanded claims bring the approved indications for VivaGel® BV (Fleurstat BVgel) in line with those in Europe and Asia.Read More
Sep 17th, 2020
Starpharma today announced that a pre-recorded presentation by Dr Jackie Fairley, CEO, will be broadcast on Thursday 17 September 2020 (US ET) as part of OTCQX’s Life Sciences Investor Forum.Read More
Sep 14th, 2020
Starpharma today announced it has completed additional antiviral testing for SPL7013 against SARS‑CoV-2 in studies conducted in the laboratory of internationally recognised virology researcher, Professor Philippe Gallay, at the renowned Scripps Research Institute in the US.Read More
Sep 3rd, 2020
Starpharma today announced the award of $1 million in matched funding by the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program to expedite development and commercialisation of its COVID‑19 antiviral nasal spray based on Starpharma’s proprietary dendrimer, SPL7013.
Sep 1st, 2020
Starpharma today announced it has applied its novel DEP® drug delivery technology to create a long‑acting, water soluble version of remdesivir. Remdesivir is an antiviral drug, currently being developed by Gilead to treat COVID-19 and has emergency use authorisation from the US Food and Drug Administration for the treatment of COVID-19 in adults and children hospitalised with severe disease.Read More
Aug 25th, 2020
Starpharma today announced progress with development, regulatory and manufacturing activities associated with a nasal spray for protection against COVID-19 based on the company’s proprietary antiviral dendrimer, SPL7013.Read More
Aug 17th, 2020
Starpharma today announced that it has signed a new research partnership with leading Chinese Pharmaceutical company Tianjin Chase Sun Pharmaceutical Co., Ltd. (stock code 300026; Chase Sun), to develop several DEP® nanoparticle formulations for an anti-infective drug. The agreement also provides for the potential to conduct additional DEP® programs, which can be across therapeutic areas beyond anti-infectives.
Jul 30th, 2020
Starpharma today announced that it has commenced its DEP® docetaxel + gemcitabine combination study for patients with advanced cancers, including pancreatic cancer. Recruitment into the study has commenced at the Christie in the UK, with two further sites expected to open in the coming weeks.
Jul 27th, 2020
Starpharma (ASX: SPL, OTCQX: SPHRY) today announced the opening of the MD Anderson Cancer Center as a further trial site for the phase 1 trial of AZD0466, AstraZeneca’s first DEP® product.Read More
Jul 9th, 2020
Starpharma today announced the opening of a new trial site for the phase 2 DEP® irinotecan trial, at the Kinghorn Cancer Centre in Sydney. The DEP® irinotecan trial is also being conducted at multiple leading UK cancer centres including The Christie, The Royal Marsden, Newcastle Freeman Hospital, and The Beatson West of Scotland Cancer Centre. The Kinghorn Cancer Centre will also be opened shortly as an additional site for the phase 2 DEP® cabazitaxel trial.
Jul 3rd, 2020
The Age recently interviewed Starpharma CEO Dr Jackie Fairley to discuss how the COVID19 pandemic could be the catalyst for the pharmaceutical industry to improve the way they convert important research into commercial products. The article highlighted Starpharma’s recent activities in response to the pandemic, including the development of a product using its existing anti-viral dendrimer SPL7013.
To read the full article, click here.Read More
Jun 29th, 2020
Starpharma today announced its SN-38 nanoparticle, DEP® irinotecan in combination with an immuno-oncology (IO) agent (anti PD-1 antibody) showed superior anti-tumour activity and significant survival benefit in two colorectal cancer (CRC) models when compared to the anti PD-1 antibody alone. These results included improvement in both survival and efficacy in the particularly aggressive CT-26 CRC model.Read More
Jun 25th, 2020
Alan Kohler recently interviewed Starpharma CEO Dr Jackie Fairley on the ABC’s 7.30 report to discuss the importance of developing other methods of protection against COVID-19 while we wait for a vaccine. Jackie also discusses how Starpharma’s patented dendrimer SPL7013 is being developed for use in an antiviral nasal spray to prevent COVID-19 infection.
Watch the full interview here: https://www.abc.net.au/7.30/how-long-will-the-economy-take-to-recover/12394342Read More
Jun 23rd, 2020
Starpharma today announced that five posters featuring products based on Starpharma’s DEP® platform have been presented at the AACR (American Association for Cancer Research) Annual Meeting. The AACR Annual Meeting brings together leading cancer research and medicine from institutions all over the world and is an important forum for both raising product awareness and commercial interactions.Read More
Jun 18th, 2020
Starpharma today announced that a pre-recorded presentation by Dr Jackie Fairley, CEO, will be broadcast on Thursday 18 June 2020 (US ET) as part of OTCQX’s Virtual Investor Conference for Global Mid-cap and Large-cap Companies. The conference is primarily attended by US-based retail investors, as well as advisors.
Jun 17th, 2020
Starpharma today announced results from its first radiotherapeutic candidate, DEP® lutetium. DEP® lutetium is a patented nanoparticle which incorporates the radioisotope Lutetium-177 on a DEP® dendrimer scaffold.
Jun 16th, 2020
Starpharma today announced that VivaGel® BV has been launched in Central and Eastern European (CEE) region. This launch follows European launches in Germany, UK and several other European countries.Read More
May 14th, 2020
In this issue:
>> VivaGel® BV launched in Asia
>> Fleurstat BVgel launched in NZ
>> DEP® irinotecan phase 2 commences after positive phase 1 results
>> SPL7013 against SARS-COV-2 (coronavirus)
>> Fleurstat BVgel ranks as #1 topical BV treatment
>> Okamoto adds 11 more Asian countries to licence
>> US regulatory update
>> COVID-19: Starpharma’s operations continue with minimal disruption
>> DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan
>> DEP® patient case studies
>> AstraZeneca’s DEP® trial ongoing in the US & US$3 million milestone payment received
>> New DEP® ADC programs
>> DEP® pipeline targets multiple high-value areas
>> Other DEP® programs
>> Outlook, recent news & events
May 7th, 2020
Starpharma today announced successful completion of the phase 1 component of its phase 1 / 2 trial for DEP® irinotecan. The trial met its objective of evaluating safety, tolerability, pharmacokinetics and preliminary efficacy data, and identifying a recommended phase 2 dose. The trial will now transition seamlessly into phase 2, with recruitment activities underway at three sites. Two additional sites, The Beatson West of Scotland Cancer Centre (the Beatson) and the Kinghorn Cancer Centre in Sydney are also expected to commence recruitment shortly.Read More
May 5th, 2020
Starpharma has been invited to present today at the Macquarie Australia Conference. Due to COVID-19, the Macquarie Australia Conference will be a virtual conference for registered institutional investors. The event will provide international and domestic institutions with the opportunity to hear from a range of invited Australian companies over three days. Starpharma is one of a handful of companies in the pharmaceutical/biotech and healthcare industries to be presenting during the conference.Read More
Apr 15th, 2020
Starpharma today announced that its proprietary VivaGel® active, astodrimer sodium (SPL7013), has been shown in laboratory studies to have significant antiviral activity against the coronavirus that causes COVID-19 (coronavirus disease). SPL7013 inhibited the infection of cells with the SARS-CoV-2 virus and the finding was validated by replicate testing against a positive control compound, remdesivir (Gilead), which is considered a leading candidate for the treatment of COVID-19. The finding was also significant given that SPL7013 was reported to be the best performing test compound against SARS-CoV-2 in the laboratory’s assay to date. With these positive results, Starpharma is evaluating product concepts and formulation options for SPL7013, which may have potential applications in the prevention and management of COVID-19.
Apr 7th, 2020
Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2020.
Starpharma’s cash balance as at 31 March 2020 was $36.1 million, an increase of $0.2 million compared to the previous quarter’s cash balance. Net operating cash outflows for the quarter were $0.9 million, or $6.0 million for the nine months to 31 March 2020. Starpharma’s strong cash reserves and clean balance sheet places the Company in a strong position to continue to progress its commercial and R&D activities in the current uncertain global environment of the COVID-19 pandemic.Read More
Mar 4th, 2020
Starpharma today announced that following the successful launch of the VivaGel® antiviral condom by Okamoto Industries, Inc. (TYO: 5122:JP; Okamoto) in Japan, Okamoto has sought an expansion to its licence territory for the VivaGel® condom. As a result, Starpharma has granted Okamoto marketing rights to a further 11 countries in Asia which include South Korea, Indonesia, Malaysia, Thailand, Singapore and the non-government China market.
Mar 2nd, 2020
Starpharma today announced that Mr David McIntyre has commenced as an independent non-executive director of Starpharma, effective 1 March. Mr McIntyre’s appointment follows a comprehensive Board renewal and search process. As advised at the Company’s last AGM, Mr Richard Hazleton will be retiring at the 2020 AGM in November, having served 13 years on the Company’s Board. The timing of Mr McIntyre’s appointment enables a smooth transition and handover between directors.